Manager of Quality Engineering

Biotalent - San Diego, CA

Full-time - Mid Level

San Diego, CA

Administrative and Support Services

About the position

The Quality Director will oversee and implement quality control processes, procedures, and inspections to maintain and improve product quality while expanding manufacturing capabilities. This role is crucial for ensuring that products and processes consistently meet quality standards, customer expectations, and comply with industry regulations. The Quality Director will focus on developing and implementing quality measures, supporting product verifications, and collaborating with cross-functional teams to drive continuous improvement in operations.

Responsibilities

• Consistently apply core values (Integrity, Impact, Dedication) in decision-making and interactions.
• Uphold and enhance the quality policy commitment through continuous improvement, customer focus, team collaboration, and compliance.
• Develop and execute validation tests for equipment, processes, or systems in the manufacturing environment, documenting outcomes to ensure compliance with established criteria.
• Conduct risk assessments and take corrective actions to mitigate identified risks.
• Support and perform inspections to ensure compliance with quality specifications and standards using various tools such as vision systems and gauges.
• Develop and monitor quality control procedures to adhere to quality standards.
• Identify and resolve quality issues promptly, implementing corrective actions to prevent recurrence.
• Use statistical tools to make informed decisions about product and process quality.
• Schedule calibration and preventive maintenance to ensure equipment reliability.
• Engage in root cause analysis and continuous improvement activities to enhance process efficiency.
• Train personnel on quality control procedures and industry best practices.
• Ensure compliance with industry standards and regulatory requirements.
• Drive initiatives to enhance the efficiency and effectiveness of quality control processes.

Requirements

• Bachelor's degree in engineering or related field with 4-8 years relevant experience; Master's degree preferred.
• Additional 3-8 years in quality control or related roles.
• Experience with quality control software and tools preferred.
• Six Sigma Certification, Black Belt preferred.
• Management experience preferred.
• Knowledge of ISO 13485 and FDA CFR 820 requirements.
• Strong understanding of quality control principles and methods.
• Proficient in measurement and inspection equipment.
• Detail-oriented with excellent problem-solving skills.
• Effective communication and teamwork abilities.

Nice-to-haves

• Experience with quality control software and tools preferred.
• Six Sigma Certification, Black Belt preferred.
• Management experience preferred.

Benefits

• Medical, Vision, and Dental Insurance
• Short Term Disability
• 401(k) plus match
• Vacation days
• Paid holidays